Intra-lesional Tumor Boost for Bulky Cervical Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age19-80
SponsorSeoul National University Bundang Hospital
About this trial
The goal of this clinical trial is to learn if adding a radiation boost (intra-lesional boost) works to treat patients with large-sized cervical cancer. It will also learn about the safety of this treatment. The main questions it aims to answer are:
* Does the extra radiation boost effectively reduce the tumor size before the internal radiation (brachytherapy) treatment begins? * What medical problems (side effects) do participants have when receiving this treatment?
Researchers will give this intra-lesional boost to all participants during their standard radiation therapy to see if it helps shrink the tumor more than usual.
Participants will:
* Receive radiation therapy to the pelvis with a targeted boost to the tumor for about 5 to 6 weeks * Visit the clinic daily for radiation treatment and regularly for checkups Have an MRI scan during the 4th or 5th week of treatment to measure the tumor size * Receive internal radiation therapy (brachytherapy) after finishing the external radiation * Visit the clinic for follow-up checkups and tests for up to 2 years
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with histologically confirmed squamous cell carcinoma of the cervix.
Patients with bulky primary tumor, defined as a tumor volume ≥ 60 cc OR a maximum diameter ≥ 6 cm.
Patients aged 19 to 80 years at the time of diagnosis.
Patients with an ECOG performance status of 0 to 2.
Disqualifiers
Diagnosis of other malignancies within 5 years prior to enrollment (Exceptions: carcinoma in situ of the breast and thyroid cancer).
Patients who are medically unfit for definitive concurrent chemoradiotherapy.
Patients who have received prior chemotherapy (neoadjuvant chemotherapy) before radiation therapy.
Patients with prior history of radiation therapy to the abdomen or pelvis.
Trial design
Design model
Single group
Treatments tested in this trial
intra-lesional boost IMRT
RadiationPatients receive Whole Pelvis (+/- para-aortic field) radiotherapy 45-50.4 Gy in 25-28 fractions. An intra-lesional boost is delivered using SIB technique: 15 Gy in 3 fractions to the boost target (GTVp minus 0.7-1.0 cm margin).
High Dose Rate Brachytherapy
Procedure/SurgeryFollowed by CT or MRI-based HDR brachytherapy. Recommended dose is 27.5-30 Gy in 4-6 fractions to the HR-CTV using Iridium-192 source.
Treatment groups
17 Participants
are divided into 1 treatment groupGroup A: Intra-lesional Boost GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Proportion of Participants With Tumor Volume < 12 cc Before Brachytherapy
Tumor volume is measured using pelvic MRI volumetric analysis to determine if the intra-lesional boost successfully reduces the target volume below 12 cc.
Time frame
At 4 to 5 weeks after the start of radiation therapy (specifically at the time of 20-25 fractions)Secondary outcomes
1
Complete Remission (CR) Rate
Defined as the disappearance of all lesions on cervical examination and imaging tests.
Time frame
From treatment completion up to 2 years2
Locoregional Control Rate
Defined as the absence of tumor recurrence in the locoregional area confirmed by biopsy or imaging.
Time frame
From treatment completion up to 2 years3
Progression-Free Survival (PFS)
Assessed using the Kaplan-Meier method.
Time frame
From date of enrollment to progression or death, assessed up to 2 years4
Overall Survival (OS)
Assessed using the Kaplan-Meier method.
Time frame
From date of enrollment to death from any cause, assessed up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov